Naproxen 250mg and 500mg tablets - DM Wood Medical

Naproxen 250mg and 500mg tablets
Pharmacode
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Read this leaflet carefully before you start to
take this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Naproxen tablets are and
what they are used for
2. Before you take Naproxen tablets
3. How to take Naproxen tablets
4. Possible side effects
5. How to store
6. Further information
1. What Naproxen tablets are and what they are
used for
Naproxen belongs to a group of medicines called non-steriodal
anti-inflammatory drugs (NSAIDs), which are used to reduce
inflammation and pain in joints and muscles.
Naproxen tablets are used to treat:
• diseases of joints such as rheumatoid arthritis, osteoarthritis,
ankylosing spondylitis. Naproxen cannot cure arthritis but
is used to give relief of some symptoms such as inflammation,
swelling, stiffness and joint pain.
• attacks of gout
• muscle and bone disorders such as cervical spondylitis, low
back pain, strains and sprains, muscular pain and stiffness
(fibrositis) and inflammation of tendons (tenosynovitis).
2. Before you take Naproxen tablets
Do not take Naproxen tablets if you:
• are in the last three months of pregnancy or if you are
breast -feeding
• are allergic to naproxen or to any of the other ingredients of
Naproxen tablets (see section 6)
• are allergic to aspirin or other non-steroidal antiinflammatory
medicines (NSAIDs), or you have developed signs
of asthma (wheezing), runny nose, swelling of the skin or rash
when taking these medicines
• have or have had stomach or duodenum (gut) ulcers, bleeding
in the stomach or intestines (gastrointestinal bleeding) or have
had two or more episodes of peptic ulcers, stomach bleeding or
perforation
• have severe liver, kidney (not receiving dialysis) or heart failure
If you are not sure about any of the above conditions, please ask
your doctor.
Check with your doctor before taking Naproxen tablets
if you:
• use other non-steroidal anti-inflammatory medicines (NSAIDs) or
any medication which may cause bleeding or ulcers in the stomach
• have a history of gastrointestinal disease e.g. ulcerative colitis,
Crohn’s disease
• are elderly
• have or have had high blood pressure or any liver, kidney or
heart problems
• have or have had bronchial asthma or allergic disease
• have systemic lupus erythematosus or other connective tissue
disorders
• are a women trying to become pregnant or undergoing
investigation of infertility.
Other warnings
• Medicines such as naproxen may be associated with a small
increased risk of heart attack (myocardial infaraction) or
stroke. Any risk is more likely with high doses and prolonged
treatment. Do not exceed the recommended dose or duration of
treatment.
• If you have heart problems, previous stroke or think that you
might be at risk of these conditions (for example if you have
high blood pressure, diabetes or high cholesterol or are a
smoker) you should discuss your treatment with your doctor or
pharmacist.
• If you are elderly or frail, you have a higher risk of getting
side effects, especially from the stomach. If you experience any
unusual symptoms from the stomach you must tell your doctor
about it.
• Naproxen tablets may hide the symptoms of an infection.
Taking other medicines.
Please tell your doctor or pharmacist if you are taking, or have
recently taken, any other medicines, including medicines obtained
without a prescription. Especially:
• other NSAIDs such as aspirin or COX II inhibitors
• medicines which thin the blood or which prevent blood clotting
such as warfarin
• corticosteroids
• diuretics (“water tablets”) (e.g. furosemide)
• medicines to treat high blood pressure (e.g. captopril, ramipril
or propranolol)
• ciclosporin or tacrolimus
• mifepristone – do not take NSAIDs 8-12 days after mifepristone
• SSRI antidepressants
• zidovudine
• quinolone antibiotics
• probenecid
• methotrexate
• lithium
• hydantoins
• sulphonamides
• sulphonylureas
• cardiac glycosides (e.g. digoxin or digitoxin).
Pregnancy and breast-feeding
Naproxen may make it more difficult to become pregnant. You
should inform your doctor if you are planning to become pregnant
or if you have problems becoming pregnant.
You should not take Naproxen in the first 6 months of pregnancy
and must not take Naproxen in the last 3 months of pregnancy or
during labour.
If you are breast-feeding, you should not take Naproxen tablets.
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Driving and using machines
Naproxen may make you feel dizzy, drowsy or tired and may cause
blurred vision. Make sure you are not affected before you drive or operate
machinery.
Sugar intolerance
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine, as it contains
lactose.
Tests
If you need any blood or urine tests tell your doctor you are taking
Naproxen tablets. The tablets may need to be stopped 48 hours before a
test, as they may interefere with the results.
3. How to take Naproxen tablets
Always take Naproxen tablets exactly as your doctor has told you. If you
are not sure, check with your doctor or pharmacist.
Swallow with or after food.
Dose
Your doctor should prescribe as low a dose as possible. This will reduce any
side effects you may experience.
Adults
• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis
Initially a dose of 750mg-1g may be given then 500mg-1g a day in
two doses at twelve hour intervals, or as one dose taken in either the
morning or evening.
• Attack of gout
Initially 750mg as a single dose then 250mg every 8 hours until the
attack has passed.
• Muscle and bone disorders
Initially 500mg as a single dose then 250mg every 6-8 hours as
necessary. Up to a maximum of 1250mg a day may be given after the
first day.
Children under 16 years
Naproxen tablets should not be used in children under 16 years of age.
Elderly
Dosage may be reduced in the elderly.
If you take more Naproxen tablets than you should
It is important not to take too many tablets. Contact your doctor,
pharmacist or nearest hospital casualty department immediately if you
have taken more tablets than you should.
Symptoms of overdose are headache, feeling or being sick, heartburn,
diarrhoea, disorientation, bleeding of the stomach or intestines,
unconsciousness, drowsiness, dizziness, ringing or buzzing in the ears,
fainting, fits and excitation.
If you forget to take Naproxen tablets
If you forget to take your tablets, take your next dose as soon as you
remember, unless it is nearly time for your next dose. Do not take a double
dose to make up for one you have missed.
4. Possible side effects
Like all medicines, Naproxen tablets can cause side effects, although
not everybody gets them. If any of the side effects get worse, or if you
notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.
Stop taking Naproxen tablets and contact your doctor immediately
if you
• develop stomach or intestinal ulcers or bleeding, indigestion, heartburn
or abdominal pain (pains in your stomach) or other abnormal stomach
symptoms
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds.
Tell your doctor if you notice any of the following side effects
• Allergic reaction: an itchy skin rash, blood spots, bruising or
discolouring of the skin, red patches (erythema multiforme), a severe
rash with reddening, peeling and swelling of the skin that resembles
burns (epidermal necrolysis), or any other severe reactions like swelling
of the face, mouth, tongue or airways, feeling and being sick , difficulty
breathing or wheezing.
• Nervous system: fits, headache, ringing in the ears, a spinning
sensation, difficulty concentrating and sleeping, inflammation of the
optic nerve, disturbed vision, tingling or“pins and needles”, depression,
confusion, sensing things that are not there, dizziness, feeling of
general discomfort and illness, tiredness, drowsiness, aseptic meningitis
(may cause fever, feeling or being sick, disorientation, headache, neck
stiffness and light intolerance).
• Skin: rashes which may be red, itchy or blisters, hair loss, swelling of
the face or body, sensitivity of the skin to light, severe skin rash with
flushing, fever, blisters or ulcers (Stevens-Johnson syndrome).
• Heart: water retention, increased blood pressure and heart failure.
• Liver: abnormal liver function, hepatitis and jaundice (yellow skin or
eyes).
• Stomach and intestines: stomach, duodenal or intestinal bleeding,
ulcers or perforation, feeling or being sick, diarrhoea, wind, constipation,
inflammation of the stomach lining (gastritis), worsening of colitis and
Crohn’s disease.
• Blood: changes in the numbers and types of blood cells
(if you develop sore throats, nose bleeds or infections
consult your doctor).
• Kidneys: kidney damage or failure and blood in the urine.
• Other: hearing difficulties, swelling of the hands and
feet, lung damage, high blood potassium levels, mouth
ulcers, inflammation of blood vessels, inflammation of the
pancreas (pancreatitis).
• Medicines such as naproxen may be associated with a
small increased risk of heart attack (myocardial infarction)
or stroke.
If any of the side effects get worse, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. How to store
Keep out of the reach and sight of children.
Store below 25ºC in a dry place. Protect from light.
Do not use Naproxen tablets after the expiry date which is
stated on the label/carton/bottle. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. Further information
What Naproxen tablets contain
• The active substance (the ingredient that makes the
medicine work) is naproxen. Each tablet contains either
250mg or 500mg of the active substance.
• The other ingredients are lactose, magnesium stearate,
maize starch, polyvidone, E172, E463.
What Naproxen tablets look like and contents of
the pack
Naproxen tablets are yellow, uncoated tablets.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in September 2008
Pharmacode
Position
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50210831
Actavis, Barnstaple, EX32 8NS, UK